Committee publications
Gene therapies and orphan drugs: regulatory regime and reimbursement challenges
Argentina has established comprehensive regulations governing the use of gene therapies and orphan drugs for patients with rare diseases, as defined by Law No 26,689. This legal framework provides a foundation for tackling the unique needs of individuals with rare diseases. Despite these efforts, orphan drugs remain expensive, and reimbursement challenges persist, often requiring legal action. This article summarises the regulatory framework for these treatments and addresses the obstacles that still lie ahead.
Released on Feb 10, 2025
The intricate interplay between intellectual property and competition law as exemplified by the Xalatan case
The relationship between intellectual property and competition law becomes particularly challenging when exclusive rights are used to hinder market competition, as testified in several Italian cases and particularly in the landmark Xalatan case. The Italian Competition Authority, confirmed by the top administrative court, ruled that Pfizer’s patent strategy abusively delayed market entry from generic competitors beyond natural patent expiration by exploiting loopholes in patent regulation. Notably, this recently resulted in the top civil court to award damages to the national health service (Servizio Sanitario Nazionale or SSN) in related private damages litigation. This set of decisions, which represent landmark rulings, highlight the increasing demand to balance the protection of IP-exclusive rights with maintaining fair and competitive markets.
Released on Feb 10, 2025
Decentralised clinical trials (DCTs): steps forward in the European and Italian regulatory frameworks
The lack of clear rules for the decentralisation of clinical trials and related activities is one of the main obstacles to the widespread use of decentralised clinical trials (DCTs). The Covid-19 pandemic revealed the shortcomings of European regulatory systems, but it has also shown the enormous potential of implementing decentralised solutions for the validity and success of trials, as well as for rationalising the use of available resources. European and national authorities – including Italy – are moving towards defining a regulatory framework for DCTs that supports operators, innovation and research in the health sector.
Released on Feb 10, 2025
Increased liability due to the new EU Product Liability Directive: what does this mean for the medical and pharmaceutical industry?
The introduction of the new EU Product Liability Directive aims at leading product laws to the digital age, including stricter liability for distributing digital and AI-based products. This has significant legal implications for both consumers and manufacturers, which must be taken into account in the contractual documents along the supply chain. Now more than ever, manufacturers and providers of digital healthcare products should regularly assess potential liability risks and have their contracts checked.
Released on Feb 10, 2025
Secondary use of health data: a few hints on the EU legal landscape and how to anticipate this use in R&D contracts?
The European Union legal landscape has evolved these past years to foster the sharing of health data and support the EU’s sovereign digital single market. One important objective is to develop health data secondary use for research, development, innovation and public health policies. R&D partners will have to implement a number of principles to anticipate and organise this secondary use in their contracts.
Released on Feb 10, 2025
The use of biosimilars and regulatory challenges worldwide
The growing demand for highly complex and effective drugs, combined with the search for more affordable therapeutic options, has driven the development of biosimilar drugs. These products have similar characteristics to biological reference drugs and have been gaining ground as a viable alternative in terms of both cost and efficiency. However, their production and marketing face significant regulatory challenges in Brazil and around the world. This article explores the current scenario of biosimilars, highlighting the main regulatory challenges and trends, focusing on the Brazilian context and international practices, with special interest for the legal public and the pharmaceutical industry.
Released on Feb 10, 2025
Neurorights: Is the creation of new human rights effective in protecting human dignity from the misuse of neurotechnology?
The advance of neurotechnologies, driven by neuroscience, biomedical engineering and artificial intelligence, has brought significant benefits for health, education and security, as well as ethical and legal challenges. These advances raise questions about privacy, misuse of neural data and individual autonomy, indicating the need to regulate so-called ‘neurorights’, seeking to balance the benefits of innovation with the protection of fundamental human rights. This article addresses the challenges arising with the advance of neurotechnologies, and raises the debate on whether regulating neurorights as internationally recognised human rights would be the most efficient way to protect human dignity against possible misuse of neurotechnologies.
Released on Feb 10, 2025
Health is wealth
The article discusses the current scene as regards mergers and acquisitions (M&A) and private equity (PE) and venture capital (VC) transactions in the healthcare sector, with an emphasis on India. It further discusses the key considerations to be taken note of in light of current law, and future trends/developments in the law.
Released on Feb 10, 2025
What we talk when we talk about orphan drugs in Chile: access, research and sanitary registrations
As markets become more sophisticated and focus on fundamental human issues, scientific research in pharmaceuticals gains increasing importance. However, why do orphan drugs attract less attention in these areas? In Chile, issues related to access to these medications, research and sanitary registration of products illustrate the challenges faced by small countries in improving conditions for populations affected by rare diseases.
Released on Feb 10, 2025
The Brazilian Supreme Court’s innovative approach towards patients’ lawsuits claiming access to gene therapies
Based on the guarantees provided by the Federal Constitution, many patients seek access to treatments through court orders, including medicines without marketing authorisation from the Brazilian health regulatory agency (Anvisa) or which are not reimbursed by the public health system (Sistema Único de Saúde or SUS). This phenomenon is called health litigation. However, the Brazilian Supreme Court (STF) recently innovated the approach towards lawsuits aiming for access to a specific gene therapy, Elevidys. The case pending before the STF is a precedent that may influence future strategies of pharmaceutical companies for commercialising high-cost medicines in Brazil, involving coordinated efforts among key regulatory entities.
Released on Feb 10, 2025
Hemp in Brazil: a promising omen coming from the judiciary
In 2022, a Brazilian startup filed a lawsuit seeking the adjudication of its right to cultivate hemp and market its parts in Brazil for medicinal and industrial uses. The Superior Court of Justice (STJ) ruled in November 2024 that hemp with low THC levels cannot be considered proscribed under Brazilian law, allowing its economic exploitation for medicinal and pharmaceutical purposes. This decision mandates ANVISA to establish regulations within six months. The ruling is unprecedented, differentiating hemp from psychoactive cannabis, and emphasising the need for public policies to manage cannabis varieties.
Released on Feb 10, 2025
Early months of the updated framework for novel foods and ingredients: proactive transparency – progress and challenges
The first months of implementing Anvisa’s RDC 839/2023, which updated the regulatory framework for novel foods and ingredients in Brazil, have already brought some practical challenges for the food industry. For example, the Resolution introduced proactive transparency measures by Anvisa, reinforcing and recognising the confidentiality of the dossiers and exclusivity for companies that can demonstrate that the approvals rely on trade secrets. The purpose of this article is to briefly set out some of the progress and challenges experienced so far, providing insights into expectations for 2025.
Released on Feb 10, 2025
Safeguarding innovation: why strong patent protection is crucial for advancements in healthcare
This article examines the critical role of having robust intellectual property rights (IPR), particularly patents, when driving innovation within the healthcare sector. It highlights that strong patent protection incentivises the substantial investments required for research and development (R&D) of new medicines, medical devices and diagnostic tools. While acknowledging concerns about access to affordable healthcare, the article emphasises the importance of respecting patent rights to ensure continued advance in medical science and the development of life-saving treatments. By analysing the relevance of having patent law and the potential consequences of the wrongful use of compulsory licensing, this article advocates for a system that prioritises the protection of intellectual property as a cornerstone in healthcare innovation.
Released on Feb 10, 2025
Voluntary assisted dying laws in Australia
Voluntary assisted dying (VAD) has become legal in all states and territories in Australia except the Northern Territory following many years of debate regarding this issue. The legislation considers eligibility, checks and balances that address concerns over safeguards for patients, and legal rights and obligations of health professionals. Australian case law has held that voluntary assisted dying is not suicide under crimes legislation, however, the procedure under the VAD legislation needs to be closely followed.
Released on Feb 10, 2025
Reproductive health, IVF and surrogacy: legal and ethical issues
Complex legal and ethical issues surround assisted human reproduction, IVF and surrogacy. When does life begin? Should parents be able to select embryos in order to choose sex? Should women have the human right of reproductive freedom? What about the rights of the parents, surrogate and children? This article discusses the law in Australia and some of the leading cases in Australia and overseas.
Released on Feb 10, 2025
Electric mobility in India: an aspirational dream or a foreseeable reality?
As the world looks towards a sustainable future, India stands at the verge of a major transportation upgrade, where the promise of e-mobility shines as a tangible, foreseeable reality. As India’s urban landscape faces the challenges presented by burgeoning environmental concerns, electric vehicles emerge as a compelling solution, bridging the gap between sustainable living and economic progress.
Released on Feb 7, 2025
Pakistan's leap into the future: National Freelancing Facilitation Policy 2023
Pakistan's Ministry of Information Technology and Telecommunication (MoITT) has drafted the National Freelancing Facilitation Policy 2023, a substantial initiative aimed at strengthening its digital economy. The objective of this policy is to establish Pakistan as a prominent global centre for freelancing, thereby augmenting the average yearly income of freelancers and making a substantial contribution to the country's influx of export remittances.
Released on Feb 3, 2025
Exploring the evolving frontiers of competition law: reflections from the 28th Annual IBA Competition Conference
A conference report from the 28th Annual IBA Competition Conference, held on 6–7 September 2024 in Florence, Italy.
Released on Jan 28, 2025
Introduction on export controls: economic sanctions
Export controls refer to the regulations that identify goods, technologies and services leaving a country’s borders to ensure compliance with objectives of national security, foreign policy and domestic economic interests. Economic sanctions involve measures imposed by governments to restrict trade or financial transactions with specific countries, entities or individuals for various reasons such as national security and economic interests.
Released on Jan 27, 2025
A landscape in transformation
A report on the discussion on legal technology held at the IBA’s 7th Annual European Start-up Conference in Stockholm, taking place on 13 November 2024. Participants discussed the challenges and opportunities present by artificial intelligence, embracing change and individual responsibility for professional development.
Released on Jan 27, 2025
Seventh Annual IBA European Start-up Conference, Stockholm: report on panel session: ‘To list, to sell or to flip to the US: succesful exit methods in Europe’
A report on the panel session ‘To list, to sell or to flip to the US: sucessful exist methods in Europe’. Participants discussed recent challenges in the initial public offerings market, the ‘dual-track’ strategy and the role of legal advisors among other interesting points.
Released on Jan 27, 2025
IBA ERF announces changes to officer positions for 2025
The IBA European Regional Forum (ERF) is pleased to announce changes to its officer positions for 2025. These changes reflect the organisation's commitment to diversity, inclusion and the evolving needs of its members.
Released on Jan 27, 2025
IBA ERF activities for 2025
The year 2025 promises to be an exciting and dynamic one for the IBA European Regional Forum members. With a full calendar of events and initiatives, we look forward to engaging with our members. Here’s a preview of what’s ahead.
Released on Jan 27, 2025
Getting the best of directory submissions and how to work with your BD team
Directory submissions often feel like an administrative burden to be ticked off the list and moved on from, but they’re actually one of the most valuable tools for building credibility and strengthening your firm’s market position. In this article, the authors explore practical ways to streamline directory submissions, make collaboration more effective and ensure that your firm presents the strongest case possible.
Released on Jan 16, 2025
Webinar report: Law firms’ ESG decisions in our current geopolitical environments – a follow-up discussion after the US president elections
A report on the webinar ‘Law firms’ ESG decisions in our current geopolitical environments – a follow-up discussion after the US president elections’, held on 12 November 2024.
Released on Jan 16, 2025
News corner: China’s new Tariff Law and implementing regulation of the Law of the PRC on the Protection of Consumer Rights and Interests
On 26 April 2024, the Chinese State Council passed the Tariff Law of the People’s Republic of China, which came into force on 1 December 2024. The new law consolidates existing rules in different documents and certain practices in one administrative law.
Released on Jan 13, 2025
2023 Anti-Trust Law: new rules in China
After the unveiling of the revised Anti-Monopoly Law, amended on 2022 (the ‘AML Amendments’), 2023 has been a year of progressive antitrust legislation in China. A flurry of updated regulations and mechanism were published to further clarify the AML Amendments, absorbing the past enforcement experience, for the purpose of facilitating the implementation of the AML Amendments
Released on Jan 13, 2025
What you should know before the cross-border transfer of personal information in China
The Chinese data protection regime, along with extensive supplementary implementing regulations, exerts a comprehensive influence on data protection regulations with extraterritorial implications and significant impacts on companies conducting business in China, with a particular emphasis on the supervision of cross-border data transfers. Companies engaged in the processing of personal information of individuals residing within the territory of China during business operations may be subject to regulatory oversight, regardless of whether they are physically established in China.
Released on Jan 13, 2025
The changes in the registered capital system under the new Company Law
The Company Law of the People's Republic of China (the ‘Company Law’) is the fundamental legislation that governs the socialist market economy system. Since its initial publication in 1993, the Company Law has undergone five revisions or amendments. The sixth revision of the Company Law commenced in 2019. Following four discussions by the Standing Committee of the National People's Congress and extensive consultation with various sectors of society, the latest draft was formally reviewed and approved on 29 December 2023. It is scheduled to come into force on 1 July 2024.
Released on Jan 13, 2025
Rules on contract validity under the People’s Republic of China Civil Code
The Civil Code of the People’s Republic of China took effect on 1 January 2021. It consolidates a number of civil laws, including the general principles of civil law, property law, contract law, guarantee law, family law, succession law, tort law and specific clauses in the judicial interpretations of the Supreme Court of the People’s Republic of China.
Released on Jan 13, 2025